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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 09/11/2012
Event Type  Malfunction  
Event Description

Product analysis was completed on the patient's explanted generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Lead analysis was completed. The lead was returned in five pieces. Two large and several small pieces. A lead break was not observed during this analysis. One set of setscrew marks was found near the end of the connector pin. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. The incision, puncture and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the pulse generator at one time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a lead discontinuity. When the patient's device was programmed off they had an increase in frequency and in severity of their seizures but still the same type of seizure. The patient was injuring himself during his seizures.

 
Manufacturer Narrative

X-rays were reviewed and were not able to access the header of the generator. Pin not being fully inserted was confirmed in product analysis. Findings.

 
Event Description

A vns treating physician reported to our country representative from (b)(6) they had a vns patient who was experiencing discomfort with stimulation, coughing with interrogation/programming, possible hoarseness and had his generator disabled. Since (b)(6) 2012, the date the patient had dental procedures and ct brain/facial bones, the patient has experienced the discomfort, making noises and coughing. Information received reported that the patient has experienced recent onset of +++ discomfort , making noises at regular intervals and holding his left side of his face/ head again at regular intervals. The patient in the last 3 - 4 weeks was making noticeable abnormal noises (possibly hoarseness) every 3 mins and also holding his hand to the left side of his head again at definite intervals. The patient is moderately to severely intellectually challenged and this intolerance is not uncommon behaviour. His father also reported that this was noticeable all night long when he picked him up and travelled with him to his neurology appointment. On (b)(6) 2012, vns was interrogated and settings were: 2. 0 ma, 30 hz, 500 pw, ot 30 secs, off t 3. 0, mag 2. 25ma, ot 30 secs, diagnostics system diagnostic test dcdc 2, normal mode diagnostic test 3, telemetry ok, lead ok. On interrogation the patient coughed profusely lasting > 60 secs. At previous visits this behaviour has not been seen. At the clinic session - their output current was lowered down to. 5ma steps to 0. 25ma. With the same outcome - +++ coughing, facial flushing and hand holding left side of head for >60 secs. They also attempted to reduce hz to 20 hz at. 25ma and same results. On turning their device off all symptoms subsided. Since their vns was programmed off the patient experienced an increase in the severity of their seizures with the loss of therapy. Since the patient does not live with the person who reported their seizures their md is not sure the information is reliable. X-rays were received for review. The electrodes are visualized but it is not possible to ascertain the placement in relationship to the cervical vertebrae due to limited views. A strain relief bend and loop are present but are difficult to assess due to the film angle. The loop appears to be in a "head-on" view. Two tie downs are noted securing the lead. It is noted the strain relief bend is not secured lateral to the anchor tether. A strain relief bend was present but there was no tie down present securing the bend, there was what appeared to be a loop with one tie down. A full loop cannot be confirmed based on the angle of the pictures. Another tie down was noted near the header of the generator therefore not placed per labeling. The strain relief should be adequate to allow for full neck movement to its maximum stretched positions. Most of the lead was visible and no obvious lead discontinuities were identified. Some lead is behind the generator and this portion cannot be assessed. The lead was intact at the connector pin but based on the angle of the generator header it could not be determined if the lead pin was fully inserted or not. The filter feedthroughs appeared intact. The patient had full revision surgery and it was noted on (b)(6) 2013 that they had a lead break in the potion that was apparently covered in the x-rays by the generator. Their explanted lead has been returned for analysis and is pending completion.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device malfunction suspected, but did not cause or contribute to a death or serious injury.

 
Event Description

On (b)(6) 2013, this vns patient¿s caregiver poste a comment on social media. The caregiver reported that the patient has a vns. The system developed a fault: a fractured wire. Through ignorance of the patient¿s caregiver, the event gave the patient a very bad time for four months. Replacement took place, but the event stepped back the patient¿s progress.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2976596
Report Number1644487-2013-00503
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/30/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2008
Device MODEL Number102
Device LOT Number016065
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/03/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/18/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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